BioDesign Regulatory Services, LLC is a consulting company focused on providing regulatory services for medical device and pharmaceutical companies.
We specialize in regulatory submissions for pharmaceuticals, medical devices and biologics products.
Our in-house consulting team can help you:
Create customized FDA regulatory/development strategies.
Prepare regulatory submissions.
Maintain regulatory files, including regulatory notifications and ongoing CMC updates.
Act as a U.S. Agent for non-U.S companies.
Global Regulatory Affairs support.
CLIA-laboratory state and federal registrations.
Alex Chang, MS, RAC
Principal Consultant/ Founder
Mr. Alex Chang specializes in Regulatory Affairs and has amassed extensive submission experiences in the domestic (U.S) and international markets. This includes IND, NDA, ANDA, 510(k), PMA, DMF for the US, Design Dossier and Technical Files for the EU market.
Mr. Chang is dedicated in bringing safe, medical products into the market and holds a MS degree in Regulatory Affairs from Northeastern University, a BS degree in Biological Sciences from Florida International University and is RAC-certified at RAPS.
Mr. Chang is currently on track for an MBA at Santa Clara University with a concentration in Data Science and Business Analytics.